Drug delivery device with needle actuation mechanism

ABSTRACT

A drug delivery device ( 1 ) comprising a delivery unit ( 2 ) receiving a drug cartridge ( 3 ) containing a drug to be administered to a patient in need thereof, the delivery unit comprising a subcutaneous delivery mechanism ( 7 ) including a needle ( 24 ), a needle support ( 8 ) to which the needle is mounted, and a needle actuation mechanism ( 9 ) configured to move the needle from a retracted position within a housing ( 5 ) of the delivery unit ( 2 ), to an extended delivery position where the needle projects through a base wall ( 14 ) of the housing. The needle actuation mechanism comprises a rotary actuator ( 10 ) configured to engage an engagement lever ( 11 ) coupled to the needle support ( 8 ) for translating the needle support between retracted and extended delivery positions.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.17/057,728, filed Nov. 23, 2020, now U.S. Pat. No. 11,744,940, which isthe U.S. national stage application of International Patent ApplicationNo. PCT/EP2019/063269, filed May 22, 2019.

TECHNICAL FIELD

This invention relates to a drug delivery device for transcutaneousdelivery of a liquid drug, with a needle actuation mechanism.

DESCRIPTION OF RELATED ART

A drug delivery device with a needle actuation mechanism is described inWO2015015379. The needle actuation mechanism in the drug delivery devicedescribed in the aforementioned document advantageously provides areliable and safe needle actuation mechanism that can be actuated by apump drive and that does not require overcoming high spring forces of apre-stressed spring, or a complex mechanism for engagement andretraction of the needle.

Nevertheless a drawback of the aforementioned needle actuation mechanismin certain applications is that the lever arm requires a certain sizefor efficient operation. For very small drug delivery devices such assmall patch devices, in particular for drugs that are pumped in verysmall quantities such as concentrated insulin, the aforementionedmechanism is not sufficiently compact.

U.S. Pat. No. 8,535,269 describes a needle actuation system for a drugdelivery device having a needle that is mounted on a rotatable supportand that is rotated from the protected position to an active positionwhere the needle can then be inserted into a patient's skin. Afterretraction of the needle after the use of the device, the needle may bepivoted into a protected position. This mechanism is however bulky andcomplicated, which may thus also adversely affect the reliability andsafety of the device. Moreover, the provision of the needle in aprotected position prior to use, requiring rotation of the needle to anactive position prior to use, increases the complexity of the actuationof the device, making it not well adapted for automated insertion bymotorized actuation means.

It would therefore be advantageous to benefit from the advantages of asimple and reliable needle actuation mechanism yet provide this in aparticularly compact configuration.

It is also desirable to ensure the safety of the device, in particularof the disposable portions of the drug delivery device that should beprevented from be re-used once they have been used.

SUMMARY OF THE INVENTION

In view of the foregoing, an object of the invention is to provide adrug delivery device with a needle actuation mechanism that is compact,safe, and reliable.

It is advantageous to provide a drug delivery device that is economicalto produce.

It is advantageous to provide a drug delivery device that is comfortableto wear and easy to use.

Objects of the invention are achieved by a drug delivery deviceaccording to claim 1.

Objects of the invention are achieved by a drug delivery deviceaccording to claim 3.

Disclosed herein is a drug delivery device comprising a delivery unitreceiving a drug cartridge containing a drug to be administered to apatient in need thereof, the delivery unit comprising a subcutaneousdelivery mechanism including a needle, a needle support to which theneedle is mounted, and a needle actuation mechanism configured to movethe needle from a retracted position within a housing of the deliveryunit, to an extended delivery position where the needle projects througha base wall of the housing, the needle actuation mechanism comprising arotary actuator configured to engage an engagement lever coupled to theneedle support for translating the needle support between retracted andextended delivery positions.

According to a first aspect of the invention, the needle supportcomprises a translation guide member slidably mounted with respect tothe housing, and a rotation guide member rotatably mounted to thetranslation guide member, the needle being fixed to the rotation guidemember configured to tilt the needle in a fully retracted park positionafter full retraction of the needle.

According to a second aspect of the invention, the engagement lever ispivotally mounted on the needle support and elastically engages theneedle support configured to allow the engagement lever to elasticallypivot and bias against the rotary actuator of the needle actuationmechanism in the fully extended delivery position such that the rotaryactuator may turn freely in a delivery direction (R+).

In an advantageous embodiment, the needle support comprises atranslation guide member slidably mounted with respect to the housing,and a rotation guide member rotatably mounted to the translation guidemember, the needle being fixed to the rotation guide member configuredto tilt the needle in a fully retracted park position after fullretraction of the needle.

In an advantageous embodiment, the rotary actuator is coupled directlyto a rotor of a pump module mounted in the delivery unit.

In an advantageous embodiment, the rotary actuator is integrally formedwith the pump module rotor.

In an advantageous embodiment, the rotary actuator comprises a discshape with an outer peripheral rim comprising a catch formed by a recessin the rim for engaging an engagement end of the engagement lever.

In an advantageous embodiment, the engagement lever comprises asuspension biasing against the needle support for elastic pivoting ofthe engagement lever relative to the needle support.

In an advantageous embodiment, the rotation guide member comprises acylindrical body portion rotatably mounted in a rotation member supportof the translation guide member.

In an advantageous embodiment, the rotation guide member of the needlesupport comprises a liquid channel therein interconnecting a liquiddelivery conduit connected to an outlet of the pump module to the hollowneedle.

In an advantageous embodiment, the engagement lever comprises aprotuberance on a lower side of the engagement end configured forcatching on a lower catch edge of the rotary actuator when it moves in areverse direction (R−) for moving the needle from the extended deliveryposition to the retracted position.

In an advantageous embodiment, the engagement lever comprises a pivotportion and an engagement arm extending from the pivot portion to theengagement end, the pivot portion being mounted on a pivot supportextending from the rotation guide member of the needle support.

In an advantageous embodiment, the rotation guide member of the needlesupport comprises an anti-rotation guide surface slidably engaging acomplementary anti-rotation guide surface extending from the housingbase wall configured for preventing rotation of the rotation guidemember when travelling between the initial retracted position and theextended delivery position, the anti-rotation surfaces arranged todisengage in the fully retracted park position when the rotary actuatoris rotated in a reverse direction to allow tilting of the needle into afully retraced park position preventing further reuse of the needle.

In an advantageous embodiment, the tip of the needle in the fullyretracted park position engages a locking element that blocks the needlein the fully retracted park position.

In an advantageous embodiment, the locking element comprises a lockingnest filled with a soft material into which the tip of the needle burieswhen moving into the fully retracted park position. The soft materialmay advantageously comprise a thermoplastic elastomer.

In an advantageous embodiment, the locking element comprises a lockingprotrusion upstanding from the housing base wall, over which the tip ofthe needle and is blocked thereby in the tilted park position.

In an advantageous embodiment, the rotary actuator comprises a driveinterface configured for coupling to a drive mounted in a base unitcomprising an electronic control system, a power source and said pumpdrive for actuation of the rotary actuator.

In an advantageous embodiment, the delivery unit is formed as adisposable part containing said drug cartridge in a housing of thedelivery unit, and a base unit formed as a reusable part comprising anelectronic control system, a power source, and a pump drive, the baseunit being removable mountable to the delivery unit.

In an advantageous embodiment, the delivery unit comprises a mountingsurface with an adhesive layer on an underside of the base wall frommounting against a patient's skin, the drug delivery device formed as apatch device.

Further objects and advantageous features of the invention will beapparent from the claims, from the detailed description, and annexeddrawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 a is a perspective view of an embodiment of a drug deliverydevice according to the invention;

FIG. 1 b is a view similar to FIG. 1 a from another side of the device;

FIG. 1 c is a perspective view of the device of FIGS. 1 a and 1 bshowing a base unit uncoupled from a delivery unit, a cover portion ofthe delivery unit being removed to better see the inside of the deliveryunit;

FIG. 2 a is a perspective view of the delivery unit of the device ofFIGS. 1 a to 1 c with a cover portion partially removed and without adrug cartridge mounted therein;

FIG. 2 b is a view similar to FIG. 2 a showing some components of thedrug delivery unit in exploded fashion;

FIG. 3 is an exploded view of components of the delivery unit accordingto an embodiment of the invention, showing inter alia a pump module anda subcutaneous delivery mechanism of the delivery unit;

FIG. 4 is a perspective view of a subcutaneous delivery mechanism of adelivery unit according to an embodiment of the invention;

FIGS. 5 a to 5 c are cross sectional views of the drug delivery deviceillustrating a sequence of actions of the needle actuation mechanismaccording to an embodiment to the invention, FIG. 5 a showing the needleactuation mechanism in an initial state prior to first use, FIG. 5 bshowing the needle actuation mechanism in an extended delivery position,FIG. 5 c showing the needle actuation system in a fully retracted andtilted park position;

FIGS. 6 a to 6 c are perspective views of a needle support of thesubcutaneous delivery mechanism in positions corresponding to FIGS. 5 ato 5 c respectively;

FIGS. 7 a to 7 d are views of the drug delivery according to anotherembodiment of the invention, where FIG. 7 a is a cross-sectional viewshowing the needle actuation system in a fully retracted and tilted parkposition, and FIGS. 7 b to 7 d are perspective partial views of theneedle support and needle actuation mechanism in an initial state priorto first use (FIG. 7 b ), an extended delivery position (FIG. 7 c ) anda fully retracted and tilted park position (FIG. 7 d ).

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

Referring to the figures, and in particular to FIGS. 1-4 , a drugdelivery device 1 comprises a delivery unit 2 and a base unit 4. In anembodiment, the delivery unit 2 is a disposable unit 2 and is removablyconnected to the base unit 4 which may be re-usable, although it will beappreciated that in other embodiments the base may be formed with thedelivery unit as a single disposable unit.

The delivery unit 2 comprises a subcutaneous delivery mechanism 7 todeliver a fluid transdermally, a drug cartridge 3 with a reservoircontaining the fluid to be administered to a patient, a pump 6 totransfer the fluid from the reservoir to the subcutaneous deliverymechanism 7, and a support member or housing 5 for supporting theaforementioned components. A supply conduit 45 fluidly connects theoutlet of the drug cartridge 3 to the inlet 20 of the pump module 6.

The base unit 4 comprises a pump drive (not shown), a battery (notshown), an electronic control unit (not shown) and a housing. The baseunit housing may accommodate a portion of the reservoir when coupled tothe delivery unit 2 and optionally comprise one or more sensors fordetecting the drug fill level of the reservoir.

The pump module 6 is operable to pump fluid from the drug cartridge to aneedle 24 for subcutaneous delivery. In this example the pump modulecomprises a drive interface 32 configured to couple rotationally with apump drive mounted in the base unit 4 such that torque from the pumpdrive is transferred to the pump module to drive a rotor 20 of the pumpin rotation. A suitable pump engine and drive unit is provided in WO2005/039674, which is incorporated herein by reference. However, it willbe appreciated that other rotary pump engines and pump drives may beused. Moreover, the pump engine could be permanently 30 coupled orattached to a pump drive, and/or the drive could be incorporated in thedelivery unit 2 and receive power, for instance via electrical contactsor by induction from a power source (not shown) mounted in the base unit4.

An inlet 22 of the pump module 6 receives fluid from the supply conduit45 and an outlet 23 of the pump supplies fluid to the needle 24 via adelivery conduit 46.

A rotary actuator 10 of a needle actuation mechanism 9 is, in anadvantageous embodiment, mounted to the pump module 6 such that rotationof the pump rotor by the pump drive causes rotation of the rotaryactuator 10, as will be discussed in more detail in the following. Itwill be appreciated that in other embodiments the rotary actuator maynot be mounted directly onto the pump module, for example it may becoupled to the pump module via a geared system, or may alternatively bedriven separately from the drive coupled to pump module 6, for instanceby an independent motor or mechanism.

The subcutaneous delivery mechanism 7 comprises a needle support 8 and aneedle 24 mounted to the needle support adapted for trans-dermaldelivery of the fluid from the drug cartridge. The subcutaneous deliverymechanism 7 further comprises a needle actuation mechanism 9.

The needle support 8 comprises a translation guide member 12 that isslidably mounted on a needle support guide 15 fixed to the housing 5, inparticular upstanding from the base wall 14 of the housing 5. The needlesupport guide 15 comprises translation guide rails 16 that slidablyengage with guide rails 43 formed on the translation guide member 12 ofthe needle support 8. The complementary translation guide rail 16 andtranslation guide rails 43 allow slidable movement of the needle support8 relative to the base wall 14 of the housing 5 such that the needle 24can be translated from a retracted position within the housing asillustrated in FIG. 5 a and FIG. 6 a , to a delivery position extendingthrough the base wall 14 of the housing as illustrated in FIG. 5 b andFIG. 6 b for a transdermal administration of the liquid drug to apatient.

The needle support 8 further comprises a rotation guide member 13 thatis rotatably mounted to the translation guide member 12, the needle 24being fixed to the rotation guide member 13. The rotation guide member13 allows the needle 24 to be rotated from the retracted positionillustrated in FIGS. 5 a and 6 a to a fully retracted and tilted parkposition as illustrated in FIGS. 5 c and 6 c that disengages theactuation mechanism 9, thus preventing further use of the drug deliverydevice. The fully retracted and tilted park position illustrated inFIGS. 5 c and 6 c correspond to an end-of-use park position in which thedisposable delivery unit may no longer be reused and would need to bereplaced by a new delivery unit. In the end-of-use park positionillustrated in FIGS. 5 c and 6 c , the needle 24 can no longer beengaged by the actuation mechanism 9 for return to the extended deliveryposition, thus ensuring the safety of the drug delivery device after useof the delivery unit.

The translation guide member 12 comprises a rotation member support 44forming a bearing supporting a body 47, for instance a cylindricallyshaped body 47 to allow rotation of the rotation guide member 13relative to the translation guide member 12 around a rotation axis A1.

A fluid channel is formed within the rotation body fluidlyinterconnecting the hollow needle 24 to an inlet on the body 47connected to a delivery conduit 46 connected via a connector 52 to thepump module outlet 23. The conduit 46 is supple enough to allow therelative rotation between the rotation guide member 13 and the housing5.

The rotation guide member 13 is coupled to an engagement lever 11 of theneedle actuation mechanism 9. The engagement lever 11 is in theillustrated embodiment and in a preferred mode of execution, rotatablymounted to the rotation guide member 13. Within the scope of theinvention, the engagement lever may however also be fixedly mounted tothe rotation guide member and in a variant integrally formed with therotation guide member.

In the illustrated embodiment, the engagement lever 11 comprises a pivotportion 33 rotatably mounted on a pivot support 25 extending from therotation guide member 13, and an engagement arm 34 extending from thepivot portion 33 to an engagement end 35. The engagement end 35 isconfigured to be engaged by a rotary actuator 10 of the needle actuationmechanism 9.

The rotary actuator 10, which in the illustrated embodiment isessentially in the form of a disc or wheel with a circumferential outerrim 28, is provided with a catch 29 that engaged the engagement end 35when the rotary member is rotated. The catch 29 is formed by a recess ornotch 30 in the rim 28 thus presenting catch edges 31 a, 31 b whichengage respectively an upper surface and lower surface of the engagementend 35. The engagement end 35 in the retracted and extended positions asshown in FIGS. 5 a and 5 b and 6 a and 6 b extends into the notch 30.

It will be appreciated however that the rotary actuator may have variousother forms and shapes providing an element that pushes down on theengagement lever 11 when moving from the retracted to extended position,respectively having an element that engages the engagement lever to movethe lever upwards from the extended to the retracted positions, and theengagement end may also have various shapes and forms complementary tothe catch of the rotary actuator for effecting the aforementionedmovements.

In an advantageous embodiment, the rotary actuator 10 is coupled to therotor 20 of the pump module 6 and may be integrally formed as a singlepart with the pump module rotor Further, in an advantageous embodimentthe rotary actuator 10 may comprise a drive interface 32 for coupling inrotation to a drive (not shown) mounted in the base unit 4. When thedisposable unit 2 is coupled to the base unit 4, the drive interface 32engages a complementary interface of the drive in the base unit. Therotary actuator may thus be driven in rotation by the pump drive,simultaneously with the rotor of the pump module.

As best seen in FIG. 5 a , in a retracted position prior to first use ofthe delivery unit 2, the needle support 8 is in a retracted positionwith the needle 24 fully positioned within the housing 5 above the basewall 14. The engagement end 35 is in a position for engagement with thecatch 29 of the rotary actuator 10, whereby in the illustratedembodiment the engagement end 35 is positioned within the recess ornotch 30.

To use the drug delivery device 1, the delivery unit 2 is coupled andmounted to the base unit 4 such that the pump drive engages the driveinterface 32 of the rotary actuator 10. In an embodiment where thedelivery unit is provided with an adhesive base the protective film 39is peeled off and the mounting surface 38 of the base will be placedagainst the patient's skin. It may however be noted that in otherembodiments, the base wall may be provided without an adhesive layer andthe device placed against the patient's skin by other means for instanceby means of a strap or band encircling the patient's body portionagainst which the drug delivery device is placed. Upon initial use ofthe drug delivery device, for instance upon a first command to deliver adose of liquid drug subcutaneously, whereby the initial dose may besetting a basal rate of a drug delivery or a bolus injection, the pumpdrive is actuated to turn the rotary actuator in a rotation directionthat engages the engagement lever 11 and displaces it in translationfrom the retracted position to an extended delivery position asillustrated in FIGS. 5 b and 6 b such that the needle 24 pierces throughthe patient's skin and is in a position ready for delivery of the liquiddrug trans-dermally.

In the illustrated embodiment, in the extended delivery position, therotary actuator may continue rotating in the delivery direction R+. Inthe delivery direction R+ the upper engagement edge 31 b of the catch 29is configured to be able to move past the engagement end 35 such thatthe rotary actuator 10 may turn in the delivery direction continuouslyonce the needle is the extended position without being blocked by theengagement lever 11.

The engagement lever 11 may further be provided with a suspensioncoupling the lever to the rotation guide member 13.

In the variant illustrated in FIG. 4 , the suspension comprises a lowersuspension arm 36 extending from the engagement lever biasing against alower abutment shoulder 26 a extending from the rotation guide member 13configured to allow limited elastic rotation of the engagement leverrelative to the rotation guide member 13 by elastic bending of thesuspension arm 36.

This allows the rotary actuator 10 to be in contact with and pressslightly against the engagement end 35 of the engagement lever 11 whileturning in the delivery direction R+ without affecting the position ofthe needle during delivery of a drug.

In a variant, instead of a lower suspension arm 36 extending from theengagement lever 11, other elastic means may be provided, for instancethe engagement lever 11 may have a certain elasticity to allow flexiblebending thereof sufficient to accommodate contact with the rotaryactuator during rotation in the delivery direction R+.

In the variant illustrated in FIGS. 7 a to 7 d , there is no lowersuspension arm and the elasticity of the engagement lever 11 and of thesuspension arm 37 pressing against the upper abutment shoulder 26 b isconfigured to allow controlled flexible bending of the engagement leverto accommodate contact with the rotary actuator during rotation in thedelivery direction R+ without affecting the position of the needleduring delivery of a drug.

In a variant, the spring suspension element may extend from the rotationguide member 13 and press against a rigid engagement lever 11, or in thefurther variant elastic members may be provided on both the rotationguide member and the engagement lever that inter-engage. In furthervariant, the engagement lever may be integrally formed with the rotationguide member 13, for instance as a single injected part, with flexibleconnecting elements between the engagement lever and other portions ofthe rotation guide members that enable a certain flexible bendingthereof configured to allow contact during rotation in the deliveryposition yet with sufficient engagement resistance to move the needleactuation mechanism from the retracted to the extended positions. In avariant, the elastic means may be connected to an upper portion of thelever or to a lower portion of the lever provided that the function ofallowing certain flexibility in the delivery direction is provided asdiscussed above.

Once use of the delivery unit is finished, for instance when the drugcartridge is in an empty state, or after a maximum duration of use ofthe disposable delivery unit is reached, a command for retraction of thetranscutaneous needle from the extended position to the retractedposition is executed. During this operation, the pump drive iscontrolled to move in a reverse direction R− whereby the rotary actuator10 moves in the reverse direction R−. In the reverse direction, a loweredge 31 a of the catch 29 engages the engagement end 35 of theengagement lever 11 thus lifting up the needle support 8 from theextended to the retracted position. The engagement end may be providedwith a hook protrusion or other complementary element with the lowercatch edge 31 a of the rotary actuator such that upon reverse directionthe engagement lever is engaged by the catch and lifted upwards awayfrom the base wall 14.

Rotation of the rotation guide member 13 is prevented by ananti-rotation guide surface 27 on the rotation guide member slidingalong an anti-rotation guide surface 17 of the needle support guide 15on the housing 5. The anti-rotation guide surface 17 may be formed as asurface upstanding from the base wall 14. During rotation in the reversedirection R− of the rotary actuator 10 past the initial retractedposition prior to the first use illustrated in figure the needle supportis further lifted away from the base wall 14 until the complementaryanti-rotation guide surfaces 27, 17 disengage. At this moment continuedrotation in the reverse direction of the rotary actuator 10 forces therotation of the rotation guide member 13 into the fully retracted andtilted park position illustrated in FIGS. 5 c and 6 c in which it can nolonger be reengaged thus preventing reuse of the delivery unit 2.

In the illustrated embodiments, when moving into the park position, thetip of the needle 24 engages a locking element 50, 150 that blocks theneedle in the fully retracted park position.

In the embodiment illustrated in FIGS. 6 a to 6 c , when moving into thefully retracted park position, the tip of the needle 24 slips over alocking protrusion 50, as best seen in FIG. 6 c , and is then blockedand can no longer return to the unlocked position. The lockingprotrusion 50 is provided with a tapered surface on the side facing theorifice 18 to guide the needle tip as it presses elastically against thelocking protrusion, and assist it to slip over the locking protrusion50. Once in the fully retracted parked and locked position, the needletip engages in a groove and can no longer slip back to the tapered entryside of the locking protrusion. The protuberance 51 on the tip of theengagement lever 35 is configured to assist in increasing the torque onthe engagement lever 11 to allow the needle tip to slip over the lockingprotrusion.

In the embodiment illustrated in FIGS. 7 a to 7 d , when moving into thefully retracted park position, the tip of the needle 24 buries into alocking nest 150 filled with a soft material which catches the needletip, as best seen in FIG. 7 d , the needle being then blocked fromreturning to the unlocked position. The soft material may for instancebe a soft polymeric compound, for instance a thermoplastic elastomer,thermoplastic rubber, liquid silicone rubber, or similar material, thatmay be molded or deposited in a nest wall 151 of the base 14. The softmaterial may advantageously be molded in the base of the housing duringthe base molding process, in a two component molding process as per seknown in the art of injection molding.

In the illustrated embodiments, an upper suspension arm 37 extends fromthe engagement lever 11 and has a curved flexible end 37 a that thisconfigured to biased against an upper surface 48 of the housing 5. Theupper arm defines the initial position prior to first use as illustratedin FIG. 5 a and prevents upward sliding of the needle support in theinitial position. In the fully retracted park position, the upper armmay optionally also serve to block rotation of the rotation guide member13 from the retracted tilted position back to a non-tilted position. Theupper arm 37 may also serve to limit the flexible pivoting of theengagement lever during actuation and use by abutting against theabutment 26 b on the rotation guide member 13.

In an alternative variant, the needle 24 is employed for inserting aflexible cannula tube transdermally, the needle being retracted to thefully retracted park position as illustrated in FIGS. 5 c and 6 c beforefirst administration of a drug. In this alternative embodiment, theneedle does not need to be hollow and is not connected to the outlet ofthe pump module. The outlet of the pump module in such configuration isconnected to via a liquid coupling that closes the orifice through whichthe needle extends when retracted, for instance in a form of a septum orvalve such that after retraction of the needle, liquid pumped by thepump flows through the cannula that extends transdermally through thepatient's skin. The soft cannula may increase comfort of wearing thedrug delivery device by the patient especially for applications in whichthe extended use is of a few days or more. Cannula insertionconfigurations using a needle are per se known in the art and do notneed to be described further in the present application. In the fullytilted park position, in the soft cannula variant, the pump may beconfigured to rotate in either directions R+ or R−, to effect thepumping action, the engagement end of the lever being rotated away fromthe catch so that it is no long in contact with the rim of the rotaryactuator. In this regard, the upper suspension 37 may be configured toelastically engage an upper wall portion such that the tilt angle isincreased by the elastic force of the suspension in the fully retractedposition to completely disengage the engagement end 35 from the catch ofthe rotary actuator. In this instance, the rotary actuator may beconfigured to be rotated in either of the directions for the pumpingaction depending on the arrangement of the pump inlets and outlets.

List of features illustrated Drug delivery device 1  Delivery unit 2(disposable part)   Drug cartridge 3   Housing 5    Base wall 14     Upper surface portion 48      Mounting surface 38        adhesivelayer      Peel off protective film 39    Needle support guide 15     Translation guide rails 16      Anti-rotation guide surface 17   Needle outlet 18      Septum 19    Liquid supply conduit 45    Liquiddelivery conduit 46      Fluidic connector 52    Needle tip lockingelement 50, 150      Locking protrusion 50      Locking nest 150       Locking nest wall 151   Pump module 6    Rotor 20    Stator 21     Inlet 22      Outlet 23   Subcutaneous delivery mechanism 7   Needle 24    Needle support 8      Translation guide member 12       Guide rails 43        Rotation body support 44      Rotationguide member 13        Body 47        Pivot support 25        Rotationaxis A1        Abutment shoulders 26        Lower abutment shoulder 26a       Upper abutment shoulder 26b        Upper stop 49       Anti-rotation guide surface 27    Needle actuation mechanism 9     Rotary actuator 10       Rim 28       Catch 29        Recess/notch30        Catch edges 31         Upper catch edge 31b         Lowercatch edge 31a       Coupling interface 32      Engagement lever 11      Pivot portion 33       Rotation axis A2       Engagement arm 34       Engagement end 35         Protuberance 51       lower suspensionarm 36       upper suspension (arm) 37        rounded end 37a  Base unit4 (reusable part)    Electronic control system    Power source (battery)   Pump drive     Coupling interface    Status indicators 40    Userinterface (control buttons) 42

We claim:
 1. A drug delivery device comprising a delivery unit receivinga drug cartridge containing a drug to be administered to a patient inneed thereof, the delivery unit comprising a subcutaneous deliverymechanism including a needle, a needle support to which the needle ismounted, and a needle actuation mechanism configured to move the needlefrom a retracted position within a housing of the delivery unit, to anextended delivery position where the needle projects through a base wallof the housing, the needle actuation mechanism comprising a rotaryactuator configured to engage an engagement lever coupled to the needlesupport for translating the needle support between retracted andextended delivery positions, characterized in that the needle supportcomprises a translation guide member slidably mounted with respect tothe housing, and a rotation guide member rotatably mounted to thetranslation guide member, the needle being fixed to the rotation guidemember configured to tilt the needle in a fully retracted park positionafter full retraction of the needle.
 2. The device according to claim 1,wherein the engagement lever is pivotally mounted on the needle supportand elastically engages the needle support configured to allow theengagement lever to elastically pivot and bias against the rotaryactuator of the needle actuation mechanism in the fully extendeddelivery position such that the rotary actuator may turn freely in adelivery direction (R+).
 3. The device according to claim 1, wherein therotary actuator is coupled directly to a rotor of a pump module mountedin the delivery unit.
 4. The device according to claim 3, wherein therotary actuator is integrally formed with the pump module rotor.
 5. Thedevice according to claim 1, wherein the rotary actuator comprises adisc shape with an outer peripheral rim comprising a catch formed by arecess in the rim for engaging an engagement end of the engagementlever.
 6. The device according to claim 1, wherein the engagement levercomprises a suspension engaging the needle support allowing elasticpivoting of the engagement lever relative to the needle support.
 7. Thedevice according to claim 1, wherein the rotation guide member comprisesa cylindrical body portion rotatably mounted in a rotation membersupport of the translation guide member.
 8. The device according toclaim 1, wherein the rotation guide member of the needle supportcomprises a liquid channel therein interconnecting a liquid deliveryconduit connected to an outlet of the pump module to the hollow needle.9. The device according to claim 1, wherein the engagement levercomprises a protuberance on a lower side of the engagement endconfigured for catching on a lower catch edge of the rotary actuatorwhen it moves in a reverse direction (R−).
 10. The device according toclaim 1, wherein the engagement lever comprises a pivot portion and anengagement arm extending from the pivot portion to the engagement end,the pivot portion being mounted on a pivot support extending from therotation guide member of the needle support.
 11. The device according toclaim 1, wherein the rotation guide member of the needle supportcomprises an anti-rotation guide surface slidably engaging acomplementary anti-rotation guide surface extending from the housingbase wall configured for preventing rotation of the rotation guidemember when travelling between the initial retracted position and theextended delivery position, the anti-rotation surfaces arranged todisengage in the fully retracted park position when the rotary actuatoris rotated in a reverse direction to allow tilting of the needle into apark position preventing further reuse of the needle.
 12. The deviceaccording to claim 1, wherein the rotary actuator comprises a driveinterface configured for coupling to a drive mounted in a base unitcomprising an electronic control system, a power source and said pumpdrive for actuation of the rotary actuator.
 13. The device according toclaim 1, wherein the delivery unit is formed as a disposable partcontaining said drug cartridge in a housing of the delivery unit, and abase unit formed as a reusable part comprising an electronic controlsystem, a power source, and a pump drive, the base unit being removablemountable to the delivery unit.
 14. The device according to claim 1,comprising a locking element engaging the tip of the needle in the fullyretracted park position to block the needle in the park position. 15.The device according to claim 14, wherein the locking element comprisesa locking nest filled with a soft material into which the tip of theneedle buries when moving into the park position.
 16. The deviceaccording to claim 14, wherein the locking element comprises a lockingprotrusion provided with a tapered surface to guide the needle tip overthe locking protrusion.
 17. A drug delivery device comprising a deliveryunit receiving a drug cartridge containing a drug to be administered toa patient in need thereof, the delivery unit comprising a subcutaneousdelivery mechanism including a needle, a needle support to which theneedle is mounted, and a needle actuation mechanism configured to movethe needle from a retracted position within a housing of the deliveryunit, to an extended delivery position where the needle projects througha base wall of the housing, the needle actuation mechanism comprising arotary actuator configured to engage an engagement lever coupled to theneedle support for translating the needle support between retracted andextended delivery positions, wherein the engagement lever is pivotallymounted on the needle support and elastically engages the needle supportconfigured to allow the engagement lever to elastically pivot and biasagainst the rotary actuator of the needle actuation mechanism in thefully extended delivery position such that the rotary actuator may turnfreely in a delivery direction (R+).
 18. The device according to claim17, wherein the rotary actuator is coupled directly to a rotor of a pumpmodule mounted in the delivery unit.
 19. The device according to claim17, wherein the rotary actuator comprises a disc shape with an outerperipheral rim comprising a catch formed by a recess in the rim forengaging an engagement end of the engagement lever.
 20. The deviceaccording to claim 17, wherein the engagement lever comprises asuspension engaging the needle support allowing elastic pivoting of theengagement lever relative to the needle support.